{"id":8010,"date":"2026-08-25T14:46:36","date_gmt":"2026-08-25T06:46:36","guid":{"rendered":"https:\/\/rysilicone.com\/?p=8010"},"modified":"2026-08-27T14:52:59","modified_gmt":"2026-08-27T06:52:59","slug":"biocompatibility-silicone","status":"publish","type":"post","link":"https:\/\/rysilicone.com\/ja\/biocompatibility-silicone\/","title":{"rendered":"\u30b7\u30ea\u30b3\u30fc\u30f3\u306e\u751f\u4f53\u9069\u5408\u6027\uff1a\u8a66\u9a13\u3001\u898f\u683c\u3001\u304a\u3088\u3073\u88fd\u9020\u4e0a\u306e\u30ea\u30b9\u30af"},"content":{"rendered":"<p class=\"wp-block-paragraph\">\u30b7\u30ea\u30b3\u30fc\u30f3\u306f\u3001\u67d4\u8edf\u6027\u3001\u5316\u5b66\u7684\u5b89\u5b9a\u6027\u3001\u53b3\u5bc6\u306b\u7ba1\u7406\u3055\u308c\u305f\u914d\u5408\u3067\u5165\u624b\u3067\u304d\u308b\u3053\u3068\u304b\u3089\u3001\u533b\u7642\u6a5f\u5668\u306b\u3088\u304f\u9078\u3070\u308c\u307e\u3059\u3002\u554f\u984c\u306f\u3001 <a href=\"https:\/\/rysilicone.com\/ja\/medical-grade-silicone\/\">\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u30b7\u30ea\u30b3\u30f3<\/a> \u3053\u308c\u306f\u3057\u3070\u3057\u3070\u5b8c\u6210\u54c1\u306e\u627f\u8a8d\u3068\u3057\u3066\u6271\u308f\u308c\u307e\u3059\u304c\u3001\u305d\u3046\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u9854\u6599\u3001\u786c\u5316\u3001\u5f8c\u786c\u5316\u3001\u6d17\u6d44\u3001\u6ec5\u83cc\u3001\u63a5\u89e6\u6761\u4ef6\u306a\u3069\u306b\u3088\u3063\u3066\u3001\u751f\u7269\u5b66\u7684\u30ea\u30b9\u30af\u306f\u5909\u5316\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u30b7\u30ea\u30b3\u30fc\u30f3\u306e\u751f\u4f53\u9069\u5408\u6027\u306f\u3001\u672c\u8cea\u7684\u306b\u5408\u5426\u5224\u5b9a\u3067\u304d\u308b\u7279\u6027\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u305d\u308c\u306f\u3001\u7279\u5b9a\u306e\u5b8c\u6210\u54c1\u306e\u751f\u7269\u5b66\u7684\u5b89\u5168\u6027\u3067\u3042\u308a\u3001\u305d\u306e\u7d44\u6210\u3001\u88fd\u9020\u5de5\u7a0b\u3001\u8eab\u4f53\u3068\u306e\u63a5\u89e6\u5f62\u614b\u3001\u304a\u3088\u3073\u66dd\u9732\u671f\u9593\u306b\u57fa\u3065\u3044\u3066\u8a55\u4fa1\u3055\u308c\u307e\u3059\u3002.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u533a\u5225\u306b\u3088\u3063\u3066\u3001\u3088\u304f\u3042\u308b\u8abf\u9054\u30df\u30b9\u3001\u3064\u307e\u308a\u6210\u5f62\u90e8\u54c1\u3068\u305d\u306e\u5b9f\u969b\u306e\u4f7f\u7528\u6761\u4ef6\u3092\u8a55\u4fa1\u3057\u306a\u3044\u307e\u307e\u6750\u6599\u8a3c\u660e\u66f8\u3092\u627f\u8a8d\u3057\u3066\u3057\u307e\u3046\u3068\u3044\u3046\u30df\u30b9\u3092\u9632\u3050\u3053\u3068\u304c\u3067\u304d\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u30b7\u30ea\u30b3\u30fc\u30f3\u306e\u751f\u4f53\u9069\u5408\u6027\u3068\u306f\u3069\u3046\u3044\u3046\u610f\u5473\u3067\u3059\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u751f\u4f53\u9069\u5408\u6027\u3068\u306f\u3001\u6a5f\u5668\u304c\u5b9a\u3081\u3089\u308c\u305f\u4f7f\u7528\u6761\u4ef6\u4e0b\u3067\u3001\u8a31\u5bb9\u3067\u304d\u306a\u3044\u751f\u7269\u5b66\u7684\u53cd\u5fdc\u3092\u5f15\u304d\u8d77\u3053\u3059\u3053\u3068\u306a\u304f\u3001\u610f\u56f3\u3055\u308c\u305f\u6a5f\u80fd\u3092\u679c\u305f\u3059\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u305d\u306e\u6750\u6599\u304c\u751f\u7269\u5b66\u7684\u306b\u4e0d\u53ef\u8996\u3067\u3042\u308b\u3053\u3068\u3092\u610f\u5473\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u30b7\u30ea\u30b3\u30fc\u30f3\u30a8\u30e9\u30b9\u30c8\u30de\u30fc\u306f\u3001\u4e3b\u306b\u6709\u6a5f\u5074\u9396\u3092\u6301\u3064\u30b7\u30ed\u30ad\u30b5\u30f3\u9aa8\u683c\u3092\u30d9\u30fc\u30b9\u3068\u3057\u3066\u3044\u308b\u3002 <a href=\"https:\/\/rysilicone.com\/ja\/properties-of-silicone\/\">\u30b7\u30ea\u30b3\u30fc\u30f3\u30b4\u30e0\u306e\u7279\u6027<\/a> \u67d4\u8edf\u6027\u3001\u71b1\u5b89\u5b9a\u6027\u3001\u304a\u3088\u3073\u591a\u304f\u306e\u6c34\u6027\u74b0\u5883\u306b\u5bfe\u3059\u308b\u8010\u6027\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u3002\u30b7\u30ea\u30b3\u30fc\u30f3\u304c\u4f7f\u7528\u3055\u308c\u308b\u7406\u7531\u3092\u8aac\u660e\u3057\u307e\u3059\u3002 <a href=\"https:\/\/rysilicone.com\/ja\/silicone-tubing-manufacturer\/\">\u30b7\u30ea\u30b3\u30f3\u30c1\u30e5\u30fc\u30d6<\/a>, \u30ac\u30b9\u30b1\u30c3\u30c8\u3001\u547c\u5438\u5668\u90e8\u54c1\u3001\u5275\u50b7\u63a5\u89e6\u88fd\u54c1\u3001\u304a\u3088\u3073\u57cb\u3081\u8fbc\u307f\u578b\u533b\u7642\u6a5f\u5668\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u3089\u306f\u3001\u3042\u3089\u3086\u308b\u7528\u9014\u306b\u304a\u3051\u308b\u5b89\u5168\u6027\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u76ae\u819a\u63a5\u89e6\u578b\u30ac\u30b9\u30b1\u30c3\u30c8\u3001\u6d41\u4f53\u7d4c\u8def\u30c1\u30e5\u30fc\u30d6\u3001\u9577\u671f\u57cb\u3081\u8fbc\u307f\u578b\u533b\u7642\u6a5f\u5668\u306f\u3001\u305d\u308c\u305e\u308c\u7570\u306a\u308b\u7d4c\u8def\u3067\u4f53\u5185\u306b\u6709\u5bb3\u7269\u8cea\u3092\u66dd\u9732\u3057\u307e\u3059\u3002\u305d\u306e\u305f\u3081\u3001\u5fc5\u8981\u306a\u8a3c\u62e0\u306f\u6a5f\u5668\u306e\u7a2e\u985e\u306b\u5fdc\u3058\u3066\u5909\u5316\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u533b\u7642\u6a5f\u5668\u306b\u30b7\u30ea\u30b3\u30fc\u30f3\u304c\u3088\u304f\u4f7f\u308f\u308c\u308b\u306e\u306f\u306a\u305c\u3067\u3059\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u30b7\u30ea\u30b3\u30fc\u30f3\u306f\u3001\u591a\u304f\u306e\u6709\u6a5f\u30a8\u30e9\u30b9\u30c8\u30de\u30fc\u3092\u640d\u50b7\u3055\u305b\u308b\u3088\u3046\u306a\u6761\u4ef6\u4e0b\u3067\u3082\u3001\u305d\u306e\u6a5f\u68b0\u7684\u304a\u3088\u3073\u5316\u5b66\u7684\u6027\u8cea\u304c\u5b89\u5b9a\u3057\u3066\u3044\u308b\u305f\u3081\u6709\u7528\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4e3b\u306a\u5229\u70b9\u3068\u3057\u3066\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5e45\u5e83\u3044\u6e29\u5ea6\u7bc4\u56f2\u306b\u304a\u3051\u308b\u67d4\u8edf\u6027\u3002;<\/li>\n\n\n\n<li>\u6e7f\u6c17\u3084\u591a\u304f\u306e\u4e00\u822c\u7684\u306a\u5316\u5b66\u7269\u8cea\u306b\u5bfe\u3059\u308b\u8010\u6027\u3002;<\/li>\n\n\n\n<li>\u8907\u6570\u306e\u6ec5\u83cc\u65b9\u6cd5\u3068\u306e\u9069\u5408\u6027\uff08\u88fd\u5264\u306e\u59a5\u5f53\u6027\u691c\u8a3c\u304c\u5fc5\u8981\uff09\u3002;<\/li>\n\n\n\n<li>\u8868\u9762\u30a8\u30cd\u30eb\u30ae\u30fc\u304c\u4f4e\u304f\u3001\u5de5\u5177\u304b\u3089\u306e\u5265\u96e2\u304c\u5bb9\u6613\u3002;<\/li>\n\n\n\n<li>\u9ad8\u7c98\u5ea6\u30b4\u30e0\uff08HCR\uff09\u304a\u3088\u3073\u6db2\u72b6\u30b7\u30ea\u30b3\u30fc\u30f3\u30b4\u30e0\uff08LSR\uff09\u3068\u3057\u3066\u5165\u624b\u53ef\u80fd\u3067\u3059\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u540c\u3058\u8868\u9762\u5316\u5b66\u304c\u9650\u754c\u3082\u751f\u307f\u51fa\u3059\u3002 <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC8788510\/\" target=\"_blank\" rel=\"noopener\">\u751f\u4f53\u533b\u5de5\u5b66\u306b\u304a\u3051\u308bPDMS\u306e\u30ec\u30d3\u30e5\u30fc<\/a> \u5929\u7136PDMS\u306f\u758e\u6c34\u6027\u3067\u3042\u308a\u3001\u30bf\u30f3\u30d1\u30af\u8cea\u5438\u7740\u306f\u751f\u7269\u5b66\u7684\u5fdc\u7528\u306b\u304a\u3051\u308b\u7e70\u308a\u8fd4\u3057\u306e\u5236\u7d04\u3067\u3042\u308b\u3068\u6307\u6458\u3055\u308c\u3066\u3044\u308b\u3002\u8840\u6db2\u63a5\u89e6\u30c7\u30d0\u30a4\u30b9\u306e\u5834\u5408\u3001 <a href=\"https:\/\/pmc.ncbi.nlm.nih.gov\/articles\/PMC10469978\/\" target=\"_blank\" rel=\"noopener\">\u6750\u6599\u306e\u8840\u6db2\u9069\u5408\u6027\u306b\u95a2\u3059\u308b\u30ec\u30d3\u30e5\u30fc<\/a> \u5438\u7740\u3057\u305f\u8840\u6f3f\u30bf\u30f3\u30d1\u30af\u8cea\u304c\u3069\u306e\u3088\u3046\u306b\u69cb\u9020\u5909\u5316\u3092\u8d77\u3053\u3057\u3001\u8840\u5c0f\u677f\u306e\u63a5\u7740\u3068\u6d3b\u6027\u5316\u3092\u4fc3\u9032\u3057\u3001\u51dd\u56fa\u3068\u8840\u6813\u5f62\u6210\u306b\u5bc4\u4e0e\u3059\u308b\u304b\u3092\u8aac\u660e\u3059\u308b\u3002\u30b7\u30ea\u30b3\u30fc\u30f3\u306f\u81ea\u52d5\u7684\u306b\u5fae\u751f\u7269\u306e\u30b3\u30ed\u30cb\u30fc\u5f62\u6210\u306b\u8010\u6027\u304c\u3042\u308b\u308f\u3051\u3067\u306f\u306a\u3044\u3002 <a href=\"https:\/\/doi.org\/10.1021\/acsomega.1c00560\" target=\"_blank\" rel=\"noopener\">ACS Omega\u306b\u3088\u308b\u30b7\u30ea\u30b3\u30fc\u30f3\u88fd\u5c3f\u9053\u30ab\u30c6\u30fc\u30c6\u30eb\u6750\u6599\u306b\u95a2\u3059\u308b\u7814\u7a76<\/a> \u89b3\u6e2c\u3055\u308c\u305f <em>P. mirabilis<\/em> \u5f93\u6765\u306e\u30b7\u30ea\u30b3\u30fc\u30f3\u8868\u9762\u306b\u304a\u3051\u308b\u63a5\u7740\u3068\u30d0\u30a4\u30aa\u30d5\u30a3\u30eb\u30e0\u5f62\u6210\u3092\u8abf\u3079\u305f\u304c\u3001\u8868\u9762\u6539\u8cea\u306b\u3088\u3063\u3066\u7d50\u679c\u304c\u5909\u308f\u308b\u3053\u3068\u304c\u793a\u3055\u308c\u305f\u3002\u300c\u4e0d\u6d3b\u6027\u300d\u306f\u4fbf\u5229\u306a\u7565\u8a9e\u3067\u306f\u3042\u308b\u304c\u3001\u5b8c\u5168\u306a\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u3067\u306f\u306a\u3044\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-1024x576.jpg\" alt=\"\" class=\"wp-image-20828\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-1024x576.jpg 1024w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-1536x864.jpg 1536w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish-600x338.jpg 600w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-02_protein-adsorption-platelet-adhesion-publish.jpg 1672w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u306e\u30b7\u30ea\u30b3\u30fc\u30f3\u306f\u81ea\u52d5\u7684\u306b\u751f\u4f53\u9069\u5408\u6027\u3092\u6301\u3064\u306e\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u3044\u3044\u3048\u3002\u300c\u533b\u7642\u30b0\u30ec\u30fc\u30c9\u300d\u3068\u306f\u901a\u5e38\u3001\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3068\u53b3\u9078\u3055\u308c\u305f\u8a66\u9a13\u30c7\u30fc\u30bf\u306b\u3088\u3063\u3066\u88cf\u4ed8\u3051\u3089\u308c\u305f\u3001\u4f9b\u7d66\u696d\u8005\u304c\u7ba1\u7406\u3059\u308b\u88fd\u5264\u3092\u6307\u3057\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u5b8c\u6210\u54c1\u306e\u8a55\u4fa1\u306b\u4ee3\u308f\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/store.astm.org\/f2038-18.html\" target=\"_blank\" rel=\"noopener\">ASTM F2038<\/a>, \u533b\u7642\u7528\u9014\u3067\u4f7f\u7528\u3055\u308c\u308b\u30b7\u30ea\u30b3\u30fc\u30f3\u88fd\u5264\u3092\u5bfe\u8c61\u3068\u3059\u308b\u898f\u683c\u3067\u306f\u3001\u751f\u7269\u5b66\u7684\u9069\u5408\u6027\u306f\u6700\u7d42\u7684\u306b\u610f\u56f3\u3055\u308c\u305f\u7528\u9014\u3068\u306e\u95a2\u9023\u3067\u8a55\u4fa1\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3068\u898f\u5b9a\u3055\u308c\u3066\u3044\u308b\u3002\u3053\u308c\u304c\u9069\u5207\u306a\u8abf\u9054\u57fa\u6e96\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u4ee5\u524d\u306b\u8a66\u9a13\u6e08\u307f\u306e\u30b7\u30ea\u30b3\u30fc\u30f3\u3067\u3082\u3001\u4ee5\u4e0b\u306e\u3044\u305a\u308c\u304b\u306e\u5909\u66f4\u3092\u52a0\u3048\u308b\u3068\u3001\u30ea\u30b9\u30af\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u304c\u5909\u5316\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u5909\u5316<\/th><th>\u751f\u7269\u5b66\u7684\u306b\u4f55\u304c\u5909\u5316\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u304b<\/th><\/tr><\/thead><tbody><tr><td>\u9854\u6599\u307e\u305f\u306f\u30de\u30b9\u30bf\u30fc\u30d0\u30c3\u30c1<\/td><td>\u65b0\u305f\u306a\u7740\u8272\u5264\u3001\u62c5\u4f53\u3001\u307e\u305f\u306f\u4e0d\u7d14\u7269\u304c\u914d\u5408\u7269\u306b\u6df7\u5165\u3059\u308b<\/td><\/tr><tr><td>\u6cbb\u7652\u30b5\u30a4\u30af\u30eb<\/td><td>\u6b8b\u7559\u53cd\u5fdc\u7a2e\u307e\u305f\u306f\u4e0d\u5b8c\u5168\u306a\u67b6\u6a4b\u304c\u5897\u52a0\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b<\/td><\/tr><tr><td>\u6cbb\u7652\u5f8c<\/td><td>\u63ee\u767a\u6027\u6b8b\u7559\u7269\u304a\u3088\u3073\u62bd\u51fa\u7269\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306f\u5909\u5316\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059<\/td><\/tr><tr><td>\u96e2\u578b\u5264<\/td><td>\u8868\u9762\u306b\u6b8b\u7559\u7269\u304c\u4ed8\u7740\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b<\/td><\/tr><tr><td>\u6d17\u6d44\u30d7\u30ed\u30bb\u30b9<\/td><td>\u6d17\u5264\u306e\u6b8b\u7559\u7269\u3084\u5fae\u7c92\u5b50\u306b\u3088\u308b\u6c5a\u67d3\u304c\u6b8b\u3063\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/td><\/tr><tr><td>\u6bba\u83cc<\/td><td>\u9178\u5316\u30a8\u30c1\u30ec\u30f3\u3001\u653e\u5c04\u7dda\u3001\u84b8\u6c17\u3001\u307e\u305f\u306f\u7e70\u308a\u8fd4\u3057\u30b5\u30a4\u30af\u30eb\u5f8c\u306b\u306f\u3001\u30dd\u30ea\u30de\u30fc\u306e\u7279\u6027\u3084\u62bd\u51fa\u7269\u304c\u5909\u5316\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/td><\/tr><tr><td>\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u307e\u305f\u306f\u751f\u7523\u62e0\u70b9<\/td><td>\u539f\u6750\u6599\u306e\u7ba1\u7406\u304a\u3088\u3073\u6c5a\u67d3\u7d4c\u8def\u306f\u5909\u66f4\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-1024x576.jpg\" alt=\"\" class=\"wp-image-20829\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-1024x576.jpg 1024w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-1536x864.jpg 1536w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish-600x338.jpg 600w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-03_manufacturing-biological-risk-publish.jpg 1672w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u305d\u306e\u305f\u3081\u3001\u539f\u6750\u6599\u4f9b\u7d66\u696d\u8005\u304b\u3089\u306e\u8a3c\u660e\u66f8\u306f\u3001\u5b8c\u6210\u54c1\u306b\u95a2\u3059\u308b\u7d50\u8ad6\u3067\u306f\u306a\u304f\u3001\u88cf\u4ed8\u3051\u3068\u306a\u308b\u8a3c\u62e0\u3068\u306a\u308b\u306e\u3067\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u30d7\u30e9\u30c1\u30ca\u304a\u3088\u3073\u904e\u9178\u5316\u7269\u306b\u3088\u308b\u786c\u5316\u306f\u3001\u30b7\u30ea\u30b3\u30fc\u30f3\u306e\u751f\u4f53\u9069\u5408\u6027\u306b\u3069\u306e\u3088\u3046\u306a\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u306e\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u306e <a href=\"https:\/\/rysilicone.com\/ja\/platinum-cured-vs-peroxide-cured-silicone\/\">\u30d7\u30e9\u30c1\u30ca\u304a\u3088\u3073\u904e\u9178\u5316\u7269\u786c\u5316\u30b7\u30b9\u30c6\u30e0<\/a> \u6b8b\u7559\u7269\u5236\u5fa1\u306b\u306f\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u304c\u3001\u751f\u4f53\u9069\u5408\u6027\u3092\u5358\u72ec\u3067\u6c7a\u5b9a\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3002\u691c\u8a3c\u6e08\u307f\u306e\u904e\u9178\u5316\u7269\u786c\u5316\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306f\u9069\u3057\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u4e00\u65b9\u3001\u51e6\u7406\u304c\u4e0d\u5341\u5206\u306a\u767d\u91d1\u786c\u5316\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306f\u751f\u7269\u5b66\u7684\u307e\u305f\u306f\u5316\u5b66\u7684\u8a55\u4fa1\u306b\u5408\u683c\u3057\u306a\u3044\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u8981\u7d20<\/th><th>\u30d7\u30e9\u30c1\u30ca\u786c\u5316\u30b7\u30ea\u30b3\u30fc\u30f3<\/th><th>\u904e\u9178\u5316\u7269\u786c\u5316\u30b7\u30ea\u30b3\u30fc\u30f3<\/th><\/tr><\/thead><tbody><tr><td>\u4e3b\u306a\u53cd\u5fdc<\/td><td>\u30d2\u30c9\u30ed\u30b7\u30ea\u30eb\u5316\u306b\u3088\u308b\u4ed8\u52a0\u786c\u5316<\/td><td>\u30d5\u30ea\u30fc\u30e9\u30b8\u30ab\u30eb\u67b6\u6a4b<\/td><\/tr><tr><td>\u53cd\u5fdc\u526f\u751f\u6210\u7269<\/td><td>\u5316\u5b66\u91cf\u8ad6\u7684\u306a\u53cd\u5fdc\u526f\u751f\u6210\u7269\u306f\u751f\u6210\u3057\u306a\u3044<\/td><td>\u904e\u9178\u5316\u7269\u306e\u5206\u89e3\u751f\u6210\u7269\u306f\u6b8b\u7559\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b<\/td><\/tr><tr><td>\u5178\u578b\u7684\u306a\u6b8b\u7559\u7269\u306b\u95a2\u3059\u308b\u61f8\u5ff5<\/td><td>\u672a\u53cd\u5fdc\u306e\u4f4e\u5206\u5b50\u91cf\u7269\u8cea\u3001\u89e6\u5a92\u95a2\u9023\u306e\u4e0d\u7d14\u7269\u3001\u51e6\u7406\u5de5\u7a0b\u306b\u304a\u3051\u308b\u6c5a\u67d3\u7269\u8cea<\/td><td>\u63ee\u767a\u6027\u5206\u89e3\u751f\u6210\u7269\u3001\u81ed\u6c17\u3001\u304a\u3088\u3073\u6b8b\u7559\u904e\u9178\u5316\u7269\u95a2\u9023\u7269\u8cea<\/td><\/tr><tr><td>\u6cbb\u7642\u5f8c\u306e\u6c7a\u5b9a<\/td><td>\u7528\u9014\u304a\u3088\u3073\u88fd\u5264\u306b\u4f9d\u5b58\u3059\u308b<\/td><td>\u63ee\u767a\u6027\u6b8b\u7559\u7269\u3092\u6e1b\u3089\u3057\u3001\u7279\u6027\u3092\u5b89\u5b9a\u3055\u305b\u308b\u305f\u3081\u306b\u4e00\u822c\u7684\u306b\u4f7f\u7528\u3055\u308c\u308b<\/td><\/tr><tr><td>\u9078\u629e\u30ed\u30b8\u30c3\u30af<\/td><td>\u62bd\u51fa\u6027\u306e\u4f4e\u3044\u6d41\u4f53\u7d4c\u8def\u3084\u53b3\u5bc6\u306b\u5236\u5fa1\u3055\u308c\u305f\u533b\u7642\u7528\u6210\u5f62\u306b\u3088\u304f\u7528\u3044\u3089\u308c\u308b\u3002<\/td><td>\u914d\u5408\u304a\u3088\u3073\u5f8c\u786c\u5316\u30d7\u30ed\u30bb\u30b9\u304c\u691c\u8a3c\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u306f\u3001\u5f15\u304d\u7d9a\u304d\u9069\u3057\u305f\u72b6\u614b\u3092\u7dad\u6301\u3067\u304d\u308b\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-1024x576.jpg\" alt=\"\" class=\"wp-image-20830\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-1024x576.jpg 1024w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-1536x864.jpg 1536w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish-600x338.jpg 600w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-04_platinum-peroxide-curing-comparison-publish.jpg 1672w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u88fd\u9020\u4e0a\u306e\u554f\u984c\u306f\u5358\u306b\u300c\u767d\u91d1\u304b\u904e\u9178\u5316\u7269\u304b\uff1f\u300d\u3068\u3044\u3046\u5358\u7d14\u306a\u3082\u306e\u3067\u306f\u306a\u3044\u3002\u786c\u5316\u6e29\u5ea6\u3001\u6642\u9593\u3001\u90e8\u54c1\u306e\u539a\u3055\u3001\u30aa\u30fc\u30d6\u30f3\u5185\u306e\u7a4d\u8f09\u91cf\u3001\u7a7a\u6c17\u6d41\u91cf\u3001\u304a\u3088\u3073\u786c\u5316\u5f8c\u306e\u66dd\u9732\u304c\u9069\u5207\u306b\u7ba1\u7406\u3055\u308c\u3001\u8a18\u9332\u3055\u308c\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u304c\u91cd\u8981\u306a\u306e\u3060\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u539a\u307f\u306e\u3042\u308b\u8a66\u9a13\u7247\u306f\u3001\u8584\u3044\u8a66\u9a13\u7247\u3068\u306f\u52a0\u71b1\u30fb\u6392\u6c17\u306e\u4ed5\u65b9\u304c\u7570\u306a\u308a\u307e\u3059\u3002\u5b9f\u9a13\u5ba4\u306e\u30b9\u30e9\u30d6\u3067\u691c\u8a3c\u3055\u308c\u305f\u5f8c\u786c\u5316\u51e6\u7406\u304c\u3001\u8907\u96d1\u306a\u6210\u5f62\u90e8\u54c1\u304b\u3089\u63ee\u767a\u6027\u7269\u8cea\u3092\u540c\u3058\u901f\u5ea6\u3067\u9664\u53bb\u3059\u308b\u3068\u306f\u9650\u308a\u307e\u305b\u3093\u3002\u6750\u6599\u8a3c\u660e\u66f8\u306b\u306f\u5316\u5408\u7269\u306f\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u5b8c\u6210\u54c1\u306e\u71b1\u5c65\u6b74\u306f\u8a18\u9332\u3055\u308c\u3066\u3044\u306a\u3044\u305f\u3081\u3001\u30c1\u30fc\u30e0\u306f\u3053\u306e\u70b9\u3092\u898b\u843d\u3068\u3057\u304c\u3061\u3067\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">ISO 10993-1:2025\u3067\u306f\u3001\u30b7\u30ea\u30b3\u30fc\u30f3\u306e\u751f\u4f53\u9069\u5408\u6027\u306f\u3069\u306e\u3088\u3046\u306b\u8a55\u4fa1\u3055\u308c\u308b\u306e\u3067\u3059\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.iso.org\/standard\/84512.html\" target=\"_blank\" rel=\"noopener\">ISO 10993-1:2025<\/a> \u751f\u7269\u5b66\u7684\u5b89\u5168\u6027\u306f\u3001ISO 14971\u306b\u6e96\u62e0\u3057\u305f\u30ea\u30b9\u30af\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u3068\u3057\u3066\u6271\u308f\u308c\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u3059\u3079\u3066\u306e\u30b7\u30ea\u30b3\u30fc\u30f3\u88fd\u533b\u7642\u6a5f\u5668\u304c\u5fc5\u305a\u5b9f\u65bd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u8a66\u9a13\u9805\u76ee\u306e\u56fa\u5b9a\u30ea\u30b9\u30c8\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u7c73\u56fd\u304b\u3089\u306e\u5fdc\u52df\u306e\u5834\u5408\u3001, <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfStandards\/detail.cfm?standard__identification_no=47116\" target=\"_blank\" rel=\"noopener\">FDA\u306f2025\u5e74\u7248\u3092\u90e8\u5206\u7684\u306b\u627f\u8a8d\u3057\u305f<\/a> 2026\u5e745\u670825\u65e5\u306b\u627f\u8a8d\u3055\u308c\u308b\u3002\u3053\u306e\u627f\u8a8d\u306f\u7279\u5b9a\u306e\u6761\u9805\u3092\u9664\u5916\u3057\u3066\u304a\u308a\u30012029\u5e747\u67081\u65e5\u306b\u7d42\u4e86\u3059\u308b\u79fb\u884c\u671f\u9593\u4e2d\u306f\u30012018\u5e74\u7248\u3078\u306e\u9069\u5408\u5ba3\u8a00\u3092\u5f15\u304d\u7d9a\u304d\u53d7\u3051\u5165\u308c\u308b\u3002\u3057\u305f\u304c\u3063\u3066\u3001ISO\u7248\u306e\u767a\u884c\u306f\u3001\u3059\u3079\u3066\u306e\u6761\u9805\u304cFDA\u306b\u3088\u3063\u3066\u81ea\u52d5\u7684\u306b\u627f\u8a8d\u3055\u308c\u308b\u3053\u3068\u3092\u610f\u5473\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8a55\u4fa1\u306f4\u3064\u306e\u5165\u529b\u9805\u76ee\u304b\u3089\u59cb\u307e\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u6750\u6599\u304a\u3088\u3073\u914d\u5408\u306e\u5168\u5bb9\u3002;<\/li>\n\n\n\n<li>\u88fd\u9020\u304a\u3088\u3073\u6ec5\u83cc\u30d7\u30ed\u30bb\u30b9\u3002;<\/li>\n\n\n\n<li>\u8eab\u4f53\u63a5\u89e6\u306e\u6027\u8cea\u3002;<\/li>\n\n\n\n<li>\u63a5\u89e6\u671f\u9593\u3002.<\/li>\n<\/ol>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"576\" src=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-1024x576.jpg\" alt=\"\" class=\"wp-image-20831\" srcset=\"https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-1024x576.jpg 1024w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-300x169.jpg 300w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-768x432.jpg 768w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-1536x864.jpg 1536w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-18x10.jpg 18w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish-600x338.jpg 600w, https:\/\/rysilicone.com\/wp-content\/uploads\/2024\/02\/IMG-05_iso-10993-biological-evaluation-workflow-publish.jpg 1672w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u73fe\u5728\u306e\u67a0\u7d44\u307f\u3067\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306f\u63a5\u89e6\u7d4c\u8def\uff08\u8868\u9762\u63a5\u89e6\u3001\u5916\u90e8\u901a\u4fe1\u3001\u57cb\u3081\u8fbc\u307f\u306a\u3069\uff09\u306b\u3088\u3063\u3066\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u305d\u3057\u3066\u3001\u63a5\u89e6\u6642\u9593\u3068\u30c7\u30d0\u30a4\u30b9\u56fa\u6709\u306e\u5371\u967a\u6027\u306b\u57fa\u3065\u3044\u3066\u3001\u5bfe\u51e6\u3059\u3079\u304d\u751f\u7269\u5b66\u7684\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u304c\u6c7a\u5b9a\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u306e <a href=\"https:\/\/www.fda.gov\/medical-devices\/biocompatibility-assessment-resource-center\/biocompatibility-evaluation-endpoints-device-category\" target=\"_blank\" rel=\"noopener\">FDA\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af<\/a> \u7c73\u56fd\u306b\u304a\u3051\u308b\u8a08\u753b\u7b56\u5b9a\u306e\u53c2\u8003\u8cc7\u6599\u3068\u3057\u3066\u306f\u4f9d\u7136\u3068\u3057\u3066\u6709\u7528\u3067\u3059\u304c\u3001\u3053\u308c\u306fFDA\u306e2023\u5e749\u6708\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u57fa\u3065\u3044\u3066\u3044\u307e\u3059\u3002\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u8868\u306f\u3042\u304f\u307e\u3067\u67a0\u7d44\u307f\u3067\u3042\u308a\u3001\u8a66\u9a13\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3001FDA\u306b\u3088\u308b2025\u5e74\u7248\u306e\u90e8\u5206\u7684\u306a\u627f\u8a8d\u3001\u304a\u3088\u3073\u6a5f\u5668\u56fa\u6709\u306e\u8981\u4ef6\u3068\u306e\u9593\u306e\u76f8\u9055\u70b9\u306f\u3001\u7533\u8acb\u524d\u306b\u89e3\u6c7a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u3078\u306e\u5bfe\u5fdc\u306b\u306f\u3001\u65e2\u5b58\u306e\u30c7\u30fc\u30bf\u3001\u5316\u5b66\u7684\u7279\u6027\u8a55\u4fa1\u3001\u8a66\u9a13\u3001\u307e\u305f\u306f\u79d1\u5b66\u7684\u6839\u62e0\u3092\u7528\u3044\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u3069\u306eISO 10993\u8a66\u9a13\u304c\u9069\u7528\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u304b\uff1f<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u9069\u7528\u53ef\u80fd\u306a\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u306f\u30c7\u30d0\u30a4\u30b9\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u4e00\u822c\u7684\u306a\u53c2\u7167\u5148\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u8a55\u4fa1\u5bfe\u8c61\u9818\u57df<\/th><th>\u5171\u901a\u898f\u683c<\/th><th>\u5bfe\u8c61\u3068\u3059\u308b\u5185\u5bb9<\/th><\/tr><\/thead><tbody><tr><td>\u7d30\u80de\u6bd2\u6027<\/td><td>ISO 10993-5<\/td><td>\u57f9\u990a\u7d30\u80de\u3078\u306e\u60aa\u5f71\u97ff<\/td><\/tr><tr><td>\u76ae\u819a\u611f\u4f5c<\/td><td>ISO 10993-10:2021<\/td><td>\u611f\u4f5c\u3092\u5f15\u304d\u8d77\u3053\u3059\u53ef\u80fd\u6027<\/td><\/tr><tr><td>\u523a\u6fc0<\/td><td>ISO 10993-23:2021<\/td><td>\u95a2\u9023\u3059\u308b\u63a5\u89e6\u7d4c\u8def\u306b\u304a\u3051\u308b\u523a\u6fc0\u6027<\/td><\/tr><tr><td>\u5316\u5b66\u7684\u7279\u6027\u8a55\u4fa1<\/td><td><a href=\"https:\/\/www.iso.org\/standard\/64750.html\" target=\"_blank\" rel=\"noopener\">ISO 10993-18:2020<\/a> \u2022 <a href=\"https:\/\/www.iso.org\/standard\/82241.html\" target=\"_blank\" rel=\"noopener\">Amd 1:2022<\/a><\/td><td>\u30c7\u30d0\u30a4\u30b9\u306e\u69cb\u6210\u8981\u7d20\u304a\u3088\u3073\u62bd\u51fa\u7269\u306e\u540c\u5b9a\u3068\u5b9a\u91cf<\/td><\/tr><tr><td>\u6bd2\u6027\u30ea\u30b9\u30af\u8a55\u4fa1<\/td><td><a href=\"https:\/\/www.iso.org\/standard\/75323.html\" target=\"_blank\" rel=\"noopener\">ISO 10993-17:2023<\/a> \u2022 <a href=\"https:\/\/www.iso.org\/standard\/88201.html\" target=\"_blank\" rel=\"noopener\">Amd 1:2025<\/a><\/td><td>\u7279\u5b9a\u3055\u308c\u305f\u6210\u5206\u306e\u6bd2\u6027\u5b66\u7684\u8a55\u4fa1<\/td><\/tr><tr><td>\u8840\u6db2\u9069\u5408\u6027<\/td><td>ISO 10993-4<\/td><td>\u8840\u6db2\u3068\u306e\u76f8\u4e92\u4f5c\u7528<\/td><\/tr><tr><td>\u79fb\u690d\u53cd\u5fdc<\/td><td>ISO 10993-6<\/td><td>\u79fb\u690d\u5f8c\u306e\u5c40\u6240\u7d44\u7e54\u53cd\u5fdc<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">\u7d30\u80de\u6bd2\u6027\u3001\u611f\u4f5c\u6027\u3001\u304a\u3088\u3073\u523a\u6fc0\u6027\u306f\u983b\u7e41\u306b\u8a55\u4fa1\u3055\u308c\u307e\u3059\u304c\u3001\u3053\u308c\u3089\u306f\u666e\u904d\u7684\u306a\u300c3\u3064\u306e\u8a66\u9a13\u5408\u683c\u300d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u8840\u6db2\u63a5\u89e6\u30c1\u30e5\u30fc\u30d6\u306b\u306f\u8840\u6db2\u9069\u5408\u6027\u306e\u8a3c\u660e\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u9577\u671f\u57cb\u3081\u8fbc\u307f\u578b\u533b\u7642\u6a5f\u5668\u306b\u306f\u3001\u57cb\u3081\u8fbc\u307f\u8a66\u9a13\u3001\u6162\u6027\u6bd2\u6027\u8a66\u9a13\u3001\u907a\u4f1d\u6bd2\u6027\u8a66\u9a13\u3001\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u8a66\u9a13\u304c\u5fc5\u8981\u3068\u306a\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u8a08\u753b\u306f\u6a5f\u5668\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u3088\u3063\u3066\u6c7a\u5b9a\u3055\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u306a\u305c\u5316\u5b66\u7684\u7279\u6027\u8a55\u4fa1\u306f\u3001\u3055\u3089\u306a\u308b\u8a66\u9a13\u306e\u524d\u306b\u5b9f\u65bd\u3055\u308c\u308b\u306e\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u5316\u5b66\u7684\u7279\u6027\u8a55\u4fa1\u306f\u3001\u5b8c\u6210\u3057\u305f\u30c7\u30d0\u30a4\u30b9\u304b\u3089\u79fb\u884c\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u7269\u8cea\u3092\u7279\u5b9a\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u6750\u6599\u540d\u3067\u306f\u96a0\u3055\u308c\u3066\u3044\u308b\u554f\u984c\u3001\u4f8b\u3048\u3070\u4f4e\u5206\u5b50\u91cf\u30b7\u30ed\u30ad\u30b5\u30f3\u3001\u89e6\u5a92\u6b8b\u7559\u7269\u3001\u9854\u6599\u3001\u6dfb\u52a0\u5264\u3001\u6d17\u6d44\u6b8b\u7559\u7269\u3001\u307e\u305f\u306f\u6ec5\u83cc\u95a2\u9023\u5316\u5408\u7269\u306a\u3069\u3092\u660e\u3089\u304b\u306b\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5b9f\u8df5\u7684\u306a\u624b\u9806\u306f\u4ee5\u4e0b\u306e\u3068\u304a\u308a\u3067\u3059\u3002<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u914d\u5408\u304a\u3088\u3073\u3059\u3079\u3066\u306e\u52a0\u5de5\u52a9\u5264\u3092\u6587\u66f8\u5316\u3059\u308b\u3002;<\/li>\n\n\n\n<li>\u81e8\u5e8a\u7684\u306b\u95a2\u9023\u306e\u3042\u308b\u62bd\u51fa\u6761\u4ef6\u3092\u5b9a\u7fa9\u3059\u308b\u3002;<\/li>\n\n\n\n<li>ISO 10993-18:2020\/Amd 1:2022 \u306b\u5f93\u3063\u3066\u62bd\u51fa\u7269\u3092\u7279\u5b9a\u3057\u5b9a\u91cf\u3059\u308b\u3002;<\/li>\n\n\n\n<li>ISO 10993-17:2023\/Amd 1:2025 \u306b\u57fa\u3065\u3044\u3066\u6bd2\u6027\u30ea\u30b9\u30af\u3092\u8a55\u4fa1\u3059\u308b\u3002;<\/li>\n\n\n\n<li>\u6b8b\u308a\u306e\u30c7\u30fc\u30bf\u4e0d\u8db3\u3092\u5229\u7528\u3057\u3066\u3001\u751f\u7269\u5b66\u7684\u691c\u67fb\u306e\u5b9f\u65bd\u3092\u6b63\u5f53\u5316\u3059\u308b\u3002.<\/li>\n<\/ol>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u306e\u30a2\u30d7\u30ed\u30fc\u30c1\u306f\u3001\u30c6\u30b9\u30c8\u3092\u81ea\u52d5\u7684\u306b\u6392\u9664\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u30c7\u30d0\u30a4\u30b9\u306e\u5185\u5bb9\u3092\u7406\u89e3\u3059\u308b\u524d\u306b\u3001\u30c1\u30fc\u30e0\u304c\u6a19\u6e96\u7684\u306a\u30c6\u30b9\u30c8\u30d1\u30cd\u30eb\u3092\u5b9f\u884c\u3059\u308b\u3053\u3068\u3092\u9632\u3050\u3082\u306e\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u8a66\u9a13\u5bfe\u8c61\u7269\u306f\u3001\u88fd\u9020\u5de5\u7a0b\u3092\u518d\u73fe\u3057\u305f\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002\u5e02\u8ca9\u90e8\u54c1\u306f\u5f8c\u786c\u5316\u3001\u6d17\u6d44\u3001\u7d44\u307f\u7acb\u3066\u3001\u5305\u88c5\u3001\u6ec5\u83cc\u51e6\u7406\u304c\u65bd\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u3001\u672a\u6ec5\u83cc\u306e\u6750\u6599\u30d7\u30e9\u30fc\u30af\u306f\u901a\u5e38\u3001\u9069\u5207\u306a\u4ee3\u66ff\u54c1\u3068\u306f\u306a\u308a\u5f97\u306a\u3044\u3002\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u3067\u306f\u3001\u60a3\u8005\u306e\u88ab\u3070\u304f\u91cf\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u5de5\u7a0b\u3092\u7db2\u7f85\u7684\u306b\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">USP\u30af\u30e9\u30b9VI\u306f\u4f55\u3092\u8a3c\u660e\u3057\u307e\u3059\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">USP\u30af\u30e9\u30b9VI\u306f\u3001\u8a66\u9a13\u3055\u308c\u305f\u30dd\u30ea\u30de\u30fc\u6750\u6599\u304c\u3001\u5b9a\u7fa9\u3055\u308c\u305f\u751f\u7269\u5b66\u7684\u53cd\u5fdc\u6027\u306e\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002 <a href=\"https:\/\/doi.usp.org\/USPNF\/USPNF_M98834_01_01.html\" target=\"_blank\" rel=\"noopener\">USP\u4e00\u822c\u7ae0\uff1c88\uff1e<\/a>. \u672c\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u306f\u3001\u7279\u5b9a\u306e\u62bd\u51fa\u6761\u4ef6\u4e0b\u3067\u306e\u5168\u8eab\u6ce8\u5c04\u3001\u76ae\u5185\u6ce8\u5c04\u3001\u304a\u3088\u3073\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u8a66\u9a13\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ISO 10993-1\u306b\u57fa\u3065\u304f\u5b8c\u5168\u306a\u6a5f\u5668\u306e\u751f\u4f53\u9069\u5408\u6027\u3092\u78ba\u7acb\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u8acb\u6c42<\/th><th>\u6b63\u3057\u3044\u89e3\u91c8<\/th><\/tr><\/thead><tbody><tr><td>\u201c\u300c\u3053\u306e\u30b7\u30ea\u30b3\u30fc\u30f3\u306fUSP\u30af\u30e9\u30b9VI\u3067\u3059\u3002\u300d\u201d<\/td><td>\u898f\u5b9a\u3055\u308c\u305f\u6761\u4ef6\u4e0b\u3067USP &lt;88&gt;\u306b\u5408\u683c\u3057\u305f\u3001\u5b9a\u7fa9\u3055\u308c\u305f\u6750\u6599\u307e\u305f\u306f\u8a66\u9a13\u54c1<\/td><\/tr><tr><td>\u201c\u300c\u5b8c\u6210\u3057\u305f\u88c5\u7f6e\u306f\u751f\u4f53\u9069\u5408\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u300d\u201d<\/td><td>\u63a5\u89e6\u306e\u7a2e\u985e\u3001\u671f\u9593\u3001\u51e6\u7406\u65b9\u6cd5\u3001\u304a\u3088\u3073\u4f7f\u7528\u76ee\u7684\u306b\u57fa\u3065\u3044\u305f\u30c7\u30d0\u30a4\u30b9\u56fa\u6709\u306e\u8a3c\u62e0\u304c\u5fc5\u8981\u3067\u3059\u3002<\/td><\/tr><tr><td>\u201c\u300cUSP\u30af\u30e9\u30b9VI\u306f\u3001\u3042\u3089\u3086\u308b\u63a5\u89e6\u6642\u9593\u3092\u7db2\u7f85\u3057\u3066\u3044\u307e\u3059\u3002\u300d\u201d<\/td><td>\u8aa4\u308a\u3067\u3059\u3002USP\u5206\u985e\u306fISO 10993\u30a8\u30f3\u30c9\u30dd\u30a4\u30f3\u30c8\u8a55\u4fa1\u306e\u4ee3\u66ff\u306b\u306f\u306a\u308a\u307e\u305b\u3093\u3002<\/td><\/tr><tr><td>\u201c\u300c\u4f9b\u7d66\u696d\u8005\u8a3c\u660e\u66f8\u304c\u3042\u308c\u3070\u5341\u5206\u3067\u3059\u3002\u300d\u201d<\/td><td>\u898f\u5236\u6226\u7565\u304c\u5b8c\u6210\u54c1\u3068\u540c\u7b49\u3067\u3042\u308b\u3053\u3068\u3092\u6b63\u5f53\u5316\u3057\u306a\u3044\u9650\u308a\u3001\u8aa4\u308a\u3067\u3042\u308b\u3002<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">USP\u30af\u30e9\u30b9VI\u306f\u3001\u6750\u6599\u306e\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3084\u4f9b\u7d66\u696d\u8005\u306e\u8a8d\u5b9a\u306b\u304a\u3044\u3066\u4f9d\u7136\u3068\u3057\u3066\u6709\u7528\u3067\u3042\u308b\u3002\u3088\u304f\u3042\u308b\u9593\u9055\u3044\u306f\u3001\u305d\u306e\u7d50\u679c\u3092\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u6a4b\u6e21\u3057\u306a\u3057\u306b\u3001\u9854\u6599\u3001\u6210\u5f62\u3001\u6d17\u6d44\u3001\u6ec5\u83cc\u3001\u305d\u3057\u3066\u6700\u7d42\u7684\u306a\u81e8\u5e8a\u66dd\u9732\u306b\u307e\u3067\u62e1\u5927\u3057\u3066\u3057\u307e\u3046\u3053\u3068\u3067\u3042\u308b\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u98df\u54c1\u63a5\u89e6\u57fa\u6e96\u306f\u533b\u7642\u7528\u751f\u4f53\u9069\u5408\u6027\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u3044\u3044\u3048\u3002 <a href=\"https:\/\/www.nhc.gov.cn\/sps\/c100088\/202509\/5dc5e1e2b26d4d27a7913b9e71bbe931.shtml\" target=\"_blank\" rel=\"noopener\">GB 4806.16-2025<\/a> \u3053\u308c\u306f\u30b7\u30ea\u30b3\u30fc\u30f3\u30b4\u30e0\u306e\u4e2d\u56fd\u98df\u54c1\u63a5\u89e6\u898f\u683c\u3067\u3042\u308a\u3001\u533b\u7642\u6a5f\u5668\u306e\u751f\u4f53\u9069\u5408\u6027\u898f\u683c\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002 <a href=\"https:\/\/apps.fas.usda.gov\/newgainapi\/api\/Report\/DownloadReportByFileName?fileName=National+Food+Safety+Standards+for+Food+Contact+Materials_Beijing_China+-+People%27s+Republic+of_CH2025-0216.pdf\" target=\"_blank\" rel=\"noopener\">\u7c73\u56fd\u8fb2\u52d9\u7701\u6d77\u5916\u8fb2\u696d\u5c40\u306b\u3088\u308b\u6700\u7d42\u57fa\u6e96\u306e\u7ffb\u8a33<\/a> 2026\u5e749\u67082\u65e5\u306b\u767a\u52b9\u3057\u3001\u4ed8\u9332B\u306b\u57fa\u3065\u3044\u3066\u8a66\u9a13\u3055\u308c\u305f\u63ee\u767a\u6027\u7269\u8cea\u306e\u5236\u9650\u5024\u30920.5g\/100g\uff080.5%\uff09\u306b\u8a2d\u5b9a\u3059\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u98df\u54c1\u63a5\u89e6\u306b\u95a2\u3059\u308b\u9069\u5408\u6027\u8a66\u9a13\u306f\u3001GB\/T 16886\u3001ISO 10993\u3001\u307e\u305f\u306f\u6a5f\u5668\u56fa\u6709\u306eNMPA\u8981\u4ef6\u306b\u4ee3\u308f\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u5668\u5177\u3001\u91d1\u578b\u3001\u307e\u305f\u306f\u7d66\u990c\u88fd\u54c1\u306b\u95a2\u3059\u308b\u6eb6\u51fa\u8a66\u9a13\u7d50\u679c\u306f\u3001\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u307e\u305f\u306f\u8840\u6db2\u63a5\u89e6\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3092\u8a3c\u660e\u3059\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u3069\u306e\u3088\u3046\u306a\u88fd\u9020\u7ba1\u7406\u304c\u8a66\u9a13\u7d50\u679c\u3092\u4fdd\u8b77\u3059\u308b\u306e\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u751f\u4f53\u9069\u5408\u6027\u306b\u95a2\u3059\u308b\u8a3c\u62e0\u306f\u3001\u8a66\u9a13\u5bfe\u8c61\u306e\u69cb\u6210\u304c\u7ba1\u7406\u3055\u308c\u3066\u3044\u308b\u9593\u306e\u307f\u518d\u5229\u7528\u53ef\u80fd\u3067\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u6750\u6599\u304a\u3088\u3073\u6df7\u5408\u5236\u5fa1<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u30b7\u30ea\u30b3\u30fc\u30f3\u306e\u30b0\u30ec\u30fc\u30c9\u3001\u30ed\u30c3\u30c8\u756a\u53f7\u3001\u9854\u6599\u6bd4\u7387\u3001\u6dfb\u52a0\u5264\u306e\u7a2e\u985e\u3001\u6df7\u5408\u5c65\u6b74\u3092\u8a18\u9332\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u30d9\u30fc\u30b9\u30dd\u30ea\u30de\u30fc\u306f\u5909\u66f4\u3055\u308c\u3066\u3044\u306a\u3044\u305f\u3081\u3001\u30ab\u30e9\u30fc\u30de\u30b9\u30bf\u30fc\u30d0\u30c3\u30c1\u3092\u4ee3\u7528\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044\u3002\u30ad\u30e3\u30ea\u30a2\u3068\u9854\u6599\u30b7\u30b9\u30c6\u30e0\u306f\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u306e\u5bfe\u8c61\u3068\u306a\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u786c\u5316\u304a\u3088\u3073\u5f8c\u786c\u5316\u306e\u5236\u5fa1<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u91d1\u578b\u6e29\u5ea6\u3001\u786c\u5316\u6642\u9593\u3001\u90e8\u54c1\u539a\u3055\u7bc4\u56f2\u3001\u5f8c\u786c\u5316\u6e29\u5ea6\u3001\u9732\u5149\u6642\u9593\u3001\u30aa\u30fc\u30d6\u30f3\u7a4d\u8f09\u91cf\u3001\u304a\u3088\u3073\u7a7a\u6c17\u6d41\u91cf\u3092\u5b9a\u7fa9\u3057\u307e\u3059\u3002\u591a\u30ad\u30e3\u30d3\u30c6\u30a3\u91d1\u578b\u306e\u5834\u5408\u306f\u3001\u3059\u3079\u3066\u306e\u30ad\u30e3\u30d3\u30c6\u30a3\u304c\u540c\u7b49\u306e\u30d7\u30ed\u30bb\u30b9\u30a6\u30a3\u30f3\u30c9\u30a6\u306b\u8a2d\u5b9a\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u6e05\u6383\u304a\u3088\u3073\u53d6\u308a\u6271\u3044\u306b\u95a2\u3059\u308b\u7ba1\u7406<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u96e2\u578b\u5264\u3001\u6d17\u5264\u3001\u3059\u3059\u304e\u306e\u8cea\u3001\u624b\u888b\u3001\u5bb9\u5668\u3001\u4fdd\u7ba1\u6642\u9593\u306a\u3069\u3092\u9069\u5207\u306b\u7ba1\u7406\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6e05\u6f54\u306a\u539f\u6750\u6599\u3067\u3082\u3001\u8131\u578b\u5f8c\u306b\u6c5a\u67d3\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u6ec5\u83cc\u7ba1\u7406<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u5b9f\u969b\u3092\u8a55\u4fa1\u3059\u308b <a href=\"https:\/\/rysilicone.com\/ja\/how-do-sterilization-methods-impact-medical-silicone-performance\/\">\u6ec5\u83cc\u65b9\u6cd5<\/a> \u305d\u3057\u3066\u3001\u691c\u8a3c\u6e08\u307f\u306e\u6700\u5927\u30b5\u30a4\u30af\u30eb\u6570\u3002EtO\u6b8b\u7559\u7269\u3001\u653e\u5c04\u7dda\u91cf\u3001\u84b8\u6c17\u66dd\u9732\u306f\u3001\u305d\u308c\u305e\u308c\u7570\u306a\u308b\u554f\u984c\u3092\u5f15\u304d\u8d77\u3053\u3057\u307e\u3059\u3002\u6ec5\u83cc\u524d\u306b\u30c6\u30b9\u30c8\u3055\u308c\u305f\u30c7\u30d0\u30a4\u30b9\u306f\u3001\u51fa\u8377\u3055\u308c\u308b\u88fd\u54c1\u3092\u4ee3\u8868\u3059\u308b\u3082\u306e\u3067\u306f\u306a\u3044\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">\u5909\u66f4\u7ba1\u7406<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u88fd\u5264\u3001\u4f9b\u7d66\u696d\u8005\u3001\u88fd\u9020\u5834\u6240\u3001\u5de5\u5177\u3001\u786c\u5316\u30b5\u30a4\u30af\u30eb\u3001\u6d17\u6d44\u5264\u3001\u5305\u88c5\u3001\u6ec5\u83cc\u65b9\u6cd5\u3001\u307e\u305f\u306f\u60f3\u5b9a\u3055\u308c\u308b\u63a5\u89e6\u306b\u5909\u66f4\u304c\u751f\u3058\u305f\u5834\u5408\u306f\u3001\u751f\u7269\u5b66\u7684\u30ea\u30b9\u30af\u8a55\u4fa1\u3092\u5b9f\u65bd\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u5909\u66f4\u304c\u3042\u3063\u305f\u5834\u5408\u3067\u3082\u3001\u5fc5\u305a\u3057\u3082\u3059\u3079\u3066\u306e\u8a66\u9a13\u3092\u7e70\u308a\u8fd4\u3059\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u304c\u3001\u6587\u66f8\u5316\u3055\u308c\u305f\u8a55\u4fa1\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u30b7\u30ea\u30b3\u30fc\u30f3\u90e8\u54c1\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u8cfc\u5165\u8005\u306f\u4f55\u3092\u8981\u6c42\u3059\u3079\u304d\u304b\uff1f<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f9b\u7d66\u696d\u8005\u306b\u300c\u533b\u7642\u7528\u30b7\u30ea\u30b3\u30fc\u30f3\u300d\u3092\u63d0\u4f9b\u3057\u3066\u3044\u308b\u304b\u3069\u3046\u304b\u3092\u5c0b\u306d\u308b\u4ee3\u308f\u308a\u306b\u3001\u7c21\u6f54\u306a\u8a3c\u62e0\u8cc7\u6599\u3092\u4f7f\u7528\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u201c<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6b63\u78ba\u306a\u30b7\u30ea\u30b3\u30fc\u30f3\u306e\u30b0\u30ec\u30fc\u30c9\u3068\u88fd\u9020\u5143\u3002;<\/li>\n\n\n\n<li>\u30ed\u30c3\u30c8\u8ffd\u8de1\u60c5\u5831\u304a\u3088\u3073\u5206\u6790\u8a3c\u660e\u66f8\u3002;<\/li>\n\n\n\n<li>\u8a72\u5f53\u3059\u308b\u5834\u5408\u306f\u3001\u88fd\u5264\u306e\u958b\u793a\u307e\u305f\u306f\u898f\u5236\u30de\u30b9\u30bf\u30fc\u30d5\u30a1\u30a4\u30eb\u306b\u95a2\u3059\u308b\u30b5\u30dd\u30fc\u30c8\u3002;<\/li>\n\n\n\n<li>\u786c\u5316\u30b7\u30b9\u30c6\u30e0\u304a\u3088\u3073\u691c\u8a3c\u6e08\u307f\u306e\u786c\u5316\uff0f\u5f8c\u786c\u5316\u30d1\u30e9\u30e1\u30fc\u30bf\u3002;<\/li>\n\n\n\n<li>\u9854\u6599\u304a\u3088\u3073\u6dfb\u52a0\u7269\u306e\u8b58\u5225\uff1b;<\/li>\n\n\n\n<li>\u8a66\u9a13\u5bfe\u8c61\u7269\u3092\u542b\u3080\u3001\u95a2\u9023\u3059\u308bUSP &lt;87&gt;\/&lt;88&gt;\u307e\u305f\u306fISO 10993\u30ec\u30dd\u30fc\u30c8\u3002;<\/li>\n\n\n\n<li>\u63a5\u89e6\u7d4c\u8def\u304c\u305d\u308c\u3092\u5fc5\u8981\u3068\u3059\u308b\u5834\u5408\u3001\u62bd\u51fa\u7269\u304a\u3088\u3073\u6eb6\u51fa\u7269\u306b\u95a2\u3059\u308b\u30c7\u30fc\u30bf\u3002;<\/li>\n\n\n\n<li>\u76ee\u7684\u3068\u3059\u308b\u6ec5\u83cc\u65b9\u6cd5\u306b\u304a\u3051\u308b\u6ec5\u83cc\u9069\u5408\u6027\u30c7\u30fc\u30bf\u3002;<\/li>\n\n\n\n<li>\u6d17\u6d44\u3001\u5305\u88c5\u3001\u304a\u3088\u3073\u6c5a\u67d3\u7ba1\u7406\u3002;<\/li>\n\n\n\n<li>\u5909\u66f4\u901a\u77e5\u306b\u95a2\u3059\u308b\u66f8\u9762\u306b\u3088\u308b\u5408\u610f\u3002.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">\u5831\u544a\u66f8\u306f\u3001\u540c\u7b49\u6027\u3092\u88cf\u4ed8\u3051\u308b\u305f\u3081\u306b\u3001\u4f9b\u7d66\u3055\u308c\u305f\u90e8\u54c1\u3068\u5341\u5206\u306b\u4e00\u81f4\u3057\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u6750\u6599\u306e\u30b0\u30ec\u30fc\u30c9\u3001\u8272\u3001\u88fd\u9020\u5de5\u7a0b\u3001\u6ec5\u83cc\u72b6\u614b\u3001\u62bd\u51fa\u6761\u4ef6\u3001\u304a\u3088\u3073\u5831\u544a\u66f8\u306e\u65e5\u4ed8\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u6b63\u3057\u3044\u898f\u683c\u756a\u53f7\u304c\u8a18\u8f09\u3055\u308c\u305f\u5831\u544a\u66f8\u3067\u3042\u3063\u3066\u3082\u3001\u8a66\u9a13\u30b5\u30f3\u30d7\u30eb\u304c\u4ee3\u8868\u7684\u306a\u3082\u306e\u3067\u306a\u3044\u5834\u5408\u3001\u4f7f\u7528\u3067\u304d\u306a\u3044\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">\u3088\u304f\u3042\u308b\u8cea\u554f<\/h2>\n\n\n<div id=\"rank-math-faq\" class=\"rank-math-block\">\n<div class=\"rank-math-list\">\n<div id=\"faq-question-1787813135862\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">\u30b7\u30ea\u30b3\u30f3\u306f\u808c\u306b\u89e6\u308c\u3066\u3082\u5e38\u306b\u5b89\u5168\u306a\u306e\u3067\u3057\u3087\u3046\u304b\uff1f<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u3044\u3044\u3048\u3002 <a href=\"https:\/\/rysilicone.com\/ja\/is-silicone-safe-toxicity-chemical-safety\/\">\u30b7\u30ea\u30b3\u30f3\u306e\u5b89\u5168\u6027<\/a> \u914d\u5408\u3001\u52a0\u5de5\u6b8b\u7559\u7269\u3001\u6dfb\u52a0\u7269\u3001\u63a5\u89e6\u6761\u4ef6\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u5b8c\u6210\u3057\u305f\u30c7\u30d0\u30a4\u30b9\u306b\u3064\u3044\u3066\u3082\u3001\u5225\u9014\u8a55\u4fa1\u304c\u5fc5\u8981\u3067\u3059\u3002.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1787813147122\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">\u533b\u7642\u6a5f\u5668\u306b\u306f\u30d7\u30e9\u30c1\u30ca\u786c\u5316\u30b7\u30ea\u30b3\u30fc\u30f3\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u3044\u3044\u3048\u3002\u30d7\u30e9\u30c1\u30ca\u786c\u5316\u306f\u3001\u62bd\u51fa\u6027\u306e\u4f4e\u3044\u7528\u9014\u306b\u3088\u304f\u7528\u3044\u3089\u308c\u307e\u3059\u304c\u3001\u305d\u306e\u8981\u4ef6\u306f\u6a5f\u5668\u306e\u4ed5\u69d8\u3068\u751f\u7269\u5b66\u7684\u30ea\u30b9\u30af\u8a55\u4fa1\u306b\u57fa\u3065\u3044\u3066\u3044\u307e\u3059\u3002\u691c\u8a3c\u6e08\u307f\u306e\u904e\u9178\u5316\u7269\u786c\u5316\u88fd\u5264\u3082\u9069\u3057\u3066\u3044\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1787813154718\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">USP\u30af\u30e9\u30b9VI\u306fISO 10993\u8a66\u9a13\u306b\u53d6\u3063\u3066\u4ee3\u308f\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u304b\uff1f<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u3044\u3044\u3048\u3002USP\u30af\u30e9\u30b9VI\u306f\u6750\u6599\u9078\u5b9a\u3092\u652f\u63f4\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u6a5f\u5668\u56fa\u6709\u306eISO 10993-1\u751f\u7269\u5b66\u7684\u8a55\u4fa1\u306b\u53d6\u3063\u3066\u4ee3\u308f\u308b\u3082\u306e\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-question-1787813163726\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question\">\u539f\u6750\u6599\u3068\u5b8c\u6210\u54c1\u3001\u3069\u3061\u3089\u3092\u691c\u67fb\u3059\u3079\u304d\u3067\u3057\u3087\u3046\u304b\uff1f<\/h3>\n<div class=\"rank-math-answer\">\n\n<p>\u5b8c\u6210\u54c1\u3001\u3059\u306a\u308f\u3061\u52a0\u5de5\u6e08\u307f\u306e\u6a5f\u5668\u3001\u307e\u305f\u306f\u79d1\u5b66\u7684\u306b\u59a5\u5f53\u306a\u4ee3\u8868\u7684\u306a\u8a66\u9a13\u54c1\u304c\u6700\u3082\u5f37\u529b\u306a\u8a3c\u62e0\u3068\u306a\u308b\u3002\u3053\u308c\u306b\u306f\u3001\u95a2\u9023\u3059\u308b\u786c\u5316\u3001\u6d17\u6d44\u3001\u7d44\u307f\u7acb\u3066\u3001\u5305\u88c5\u3001\u304a\u3088\u3073\u6ec5\u83cc\u306e\u5de5\u7a0b\u304c\u542b\u307e\u308c\u3066\u3044\u308b\u3079\u304d\u3067\u3042\u308b\u3002.<\/p>\n\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n\n\n<h2 class=\"wp-block-heading\">\u30c6\u30b9\u30c8\u30d7\u30e9\u30f3\u3092\u9078\u629e\u3059\u308b\u524d\u306b\u9023\u7d61\u5148\u3092\u5b9a\u7fa9\u3057\u3066\u304f\u3060\u3055\u3044<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u4f9b\u7d66\u696d\u8005\u306f\u3001\u30dd\u30ea\u30de\u30fc\u540d\u3060\u3051\u3067\u306f\u3001\u30b7\u30ea\u30b3\u30fc\u30f3\u306e\u751f\u4f53\u9069\u5408\u6027\u306b\u95a2\u3059\u308b\u78ba\u56fa\u305f\u308b\u30d1\u30c3\u30b1\u30fc\u30b8\u3092\u5b9a\u7fa9\u3059\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u6700\u4f4e\u9650\u5fc5\u8981\u306a\u60c5\u5831\u306f\u3001\u751f\u4f53\u63a5\u89e6\u7d4c\u8def\u3001\u63a5\u89e6\u6642\u9593\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u5f62\u72b6\u3001\u914d\u5408\u3001\u52a0\u5de5\u52a9\u5264\u3001\u6ec5\u83cc\u65b9\u6cd5\u3001\u5bfe\u8c61\u5e02\u5834\u3001\u305d\u3057\u3066\u90e8\u54c1\u304c\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u3068\u3057\u3066\u4f9b\u7d66\u3055\u308c\u308b\u306e\u304b\u3001\u5b8c\u6210\u54c1\u3068\u3057\u3066\u4f9b\u7d66\u3055\u308c\u308b\u306e\u304b\u3001\u3068\u3044\u3063\u305f\u70b9\u3067\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u3053\u308c\u3089\u306e\u60c5\u5831\u304c\u306a\u3051\u308c\u3070\u3001\u300cISO 10993\u30b7\u30ea\u30b3\u30fc\u30f3\u300d\u3092\u8981\u6c42\u3059\u308b\u3060\u3051\u3067\u306f\u3001\u4e0d\u660e\u78ba\u306a\u8981\u4ef6\u3092\u8cfc\u8cb7\u90e8\u9580\u306b\u6301\u3061\u8fbc\u3080\u3060\u3051\u3067\u3059\u3002\u6750\u6599\u81ea\u4f53\u306f\u9069\u5207\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u304c\u3001\u305d\u306e\u6a5f\u5668\u306b\u3068\u3063\u3066\u9069\u5207\u306a\u6839\u62e0\u304c\u4f9d\u7136\u3068\u3057\u3066\u9593\u9055\u3063\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Silicone is often selected for medical devices because it is flexible, chemically stable, and available in tightly controlled formulations. The problem is that medical-grade silicone is frequently treated as a finished-device approval. It is not. Pigments, curing, post-curing, cleaning, sterilization, and contact conditions can all change the biological risk. The biocompatibility of silicone is not an inherent pass\/fail property. It is the biological safety of a specific finished device, evaluated for its formulation, manufacturing process, body-contact type, and exposure duration. That distinction prevents a common sourcing error: approving a material certificate while leaving the molded component and its actual use conditions unevaluated. What Does the Biocompatibility of Silicone Mean? Biocompatibility [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":20827,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1013],"tags":[],"class_list":["post-8010","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-silicone-properties"],"_links":{"self":[{"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/posts\/8010","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/comments?post=8010"}],"version-history":[{"count":1,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/posts\/8010\/revisions"}],"predecessor-version":[{"id":20832,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/posts\/8010\/revisions\/20832"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/media\/20827"}],"wp:attachment":[{"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/media?parent=8010"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/categories?post=8010"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rysilicone.com\/ja\/wp-json\/wp\/v2\/tags?post=8010"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}